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Home > "Z" Clinical Trials Conditions > Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer  Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
For Condition: stage 2 breast cancer,stage 1 breast cancer,Osteoporosis
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: It is not yet known whether zoledronate is effective in preventing bone loss in premenopausal women who are receiving adjuvantchemotherapy after undergoing surgery for early stage breast cancer. PURPOSE: Randomizedphase III trial to determine the effectiveness of zoledronate in preventing bone loss in premenopausal women who are receiving chemotherapy after surgery for early stage breast cancer.
Details: OBJECTIVES: - Compare the changes in bone mineral density (BMD) and bone turnover that occur in premenopausal women with resected early stage breast cancer during and after 6 months of adjuvant chemotherapy. - Determine the factors that predict bone loss during chemotherapy, particularly induction of amenorrhea, type of chemotherapeutic regimen, glucocorticoid exposure, and baseline BMD, in these patients. - Determine whether zoledronate prevents bone loss in these patients when given during and after adjuvant chemotherapy. - Determine the effect of zoledronate on markers of bone turnover in these patients during and after adjuvant chemotherapy. - Determine whether the effect on markers of bone turnover predicts response to zoledronate in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to estrogen receptor status (positive vs negative), progesterone receptor status (positive vs negative), and adjuvant chemotherapy regimen. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive zoledronate IV over 15 minutes on day 1. - Arm II: Patients receive placebo IV over 15 minutes on day 1. In both arms, treatment repeats every 3 months for up to 4 courses in the absence of disease progression. Patients also receive calcium and cholecalciferol (vitamin D) supplements daily. Quality of life is assessed at baseline and at 6 and 12 months. Patients are followed at 1 year. PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/50 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of localized breast cancer - Stage I or II (T1-3, N0-2, M0) - Planned adjuvant chemotherapy (after surgery) of at least 6 months in duration - Hormone receptor status: - Estrogen receptor and progesterone receptor status known PATIENT CHARACTERISTICS: Age - 18 to 50 Sex - Female Menopausal status - Premenopausal or perimenopausal Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Creatinine less than 2 mg/dL Other - No T score of less than 2.0 on bone mineral density (BMD) - No fragility fracture - No lumbar spine anatomy that would preclude accurate BMD measurement of a minimum of 3 lumbar vertebrae - Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics Other - At least 1 month since prior calcitonin - At least 12 months since prior bisphosphonates given for more than 1 month duration - No concurrent fluoride therapy (10 mg/day or more) - No concurrent enrollment in another experimental drug study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DawnHershman, Study Chair, Columbia University
Carl & Dorothy Bennett Cancer Center at Stamford Hospital *Recruiting*
Stamford, Connecticut, 06902
United States
Recruiting Salvatore Del Prete 203-325-2695
Valley Hospital *Recruiting*
Paramus, New Jersey, 07652-2509
United States
Recruiting Louise Ligresti 201-634-5792
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Dawn Hershman 212-305-1945
Additional Information:
Study ID Numbers: CDR0000258105; NCI-G02-2127,CPMC-IRB-14069,NOVARTIS-CPMC-IRB-14069
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049452
Other Stage 1 Breast Cancer Studies:
1. Osteoporosis Prevention After Heart Transplant
2. Effects of Parathyroid Hormone in Men with Osteoporosis
3. Tamoxifen to Prevent Bone Loss and Heart Disease in Premenopausal Women Receiving Chemotherapy for Stage I or Stage II Breast Cancer
4. Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency
5. CVD Risk and Health in Postmenopausal Phytoestrogen Users
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Zoledronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy After Surgery For Early Stage Breast Cancer
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